MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7220-24

Device Problem Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 02/14/2018

Event Type  Injury  

Event Description

It was reported that a pump used with a cleo® 90 infusion set alarmed occlusion.The patient's blood glucose level at the time of the event was 174 mg/dl.Determined that occlusion likely occurred at device site.Patient resolved issue by administering a manual insulin injection to decrease blood glucose and replaced insulin set.No other adverse events reported.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7361797
• MDR Text Key: 103175826
• Report Number: 3012307300-2018-00785
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2022
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 77X055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HUMALOG
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 96